Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Intranasal Oxytocin | Oxytocin: Intranasal Oxytocin. Please note that the Adverse Events are not presented per dose level received, as this is not a dose-finding study, it is a modified maximum tolerated dose study. This means that a small number of participants were exposed to increasing dose levels to assess for Adverse Events. It is not meaningful to analyze adverse events by cohorts due to the extremely small sample size. | None | None | 0 | 15 | 15 | 15 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Emotional Lability | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Abdominal Discomfort | None | Gastrointestinal disorders | None | View |
| Decrease Appetite | None | Metabolism and nutrition disorders | None | View |
| Irritability | None | Psychiatric disorders | None | View |
| Headache | None | Nervous system disorders | None | View |
| Migraine | None | Nervous system disorders | None | View |
| Nausea | None | Gastrointestinal disorders | None | View |
| Upper Respiratory Infections | None | Infections and infestations | None | View |
| Rash | None | Skin and subcutaneous tissue disorders | None | View |
| Itchy Nose | None | Skin and subcutaneous tissue disorders | None | View |
| Fatigue | None | General disorders | None | View |
| Asthma Attack | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Tooth Sensitivity/Pain | None | General disorders | None | View |